To determine the response of the combination of gemcitabine and vinorelbine in patients with metastatic soft tissue sarcoma

Secondary Outcome Measures:

To determine the duration of response and the overall survival of patients with metastatic soft tissue sarcoma being treated with this combination

to evaluate the safety of this combination in this patient population

Estimated Enrollment:

40

Study Start Date:

February 2003

Study Completion Date:

June 2007

Primary Completion Date:

June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Patients will receive both gemcitabine and vinorelbine once a week for two weeks and then one week with no chemotherapy (1 cycle equals 21 days). Gemcitabine and vinorelbine will be administered on day 1 and day 8 of each cycle.

Blood tests will be performed on each day chemotherapy is administered. A CT scan will be done after every 2 cycles (approximately every 6 weeks) to determine the effects of the chemotherapy on the sarcoma.

A physical exam will be performed at the start of chemotherapy and at least every three weeks thereafter.

Patients will remain on this study as long as the disease does not progress or there are no unacceptable side effects.

Patient has received any investigational agents within 28 days of first day of study drug dosing

Two or more prior regimens for advanced disease

Prior gemcitabine or vinorelbine

Another primary malignancy

Grade III/IV cardia dysfunction

Female patients who are pregnant or breast-feeding

Severe and/or life-threatening medical disease

Known diagnosis of HIV infection

Prior chemotherapy within 4 weeks prior to study entry

Major surgery within 2 weeks prior to study entry

Known hypersensitivity to either gemcitabine or vinorelbine

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134641